Phase II Study of Biomarker-guided Neoadjuvant Treatment Strategy for IIIA-N2 Non-small Cell Lung Cancer Based on Epidermal Growth Factor Receptor Mutation Status

Overview

Journal J Hematol Oncol

Publisher Biomed Central

Specialties Hematology
Oncology

Date 2015 May 19

PMID 25981169

Citations 47

Authors

Wenzhao Zhong

Xuening Yang

Honghong Yan

Xuchao Zhang

Jian Su

Zhihong Chen

Riqiang Liao

Qiang Nie

Song Dong

Qing Zhou

Jinji Yang

Haiyan Tu

Yi-Long Wu

Affiliations

Soon will be listed here.

Abstract

Background: Neoadjuvant erlotinib and customized adjuvant therapy are appealing but controversial. The purpose of this study was to evaluate the role of biomarker-guided neoadjuvant treatment strategy in patients with IIIA-N2 non-small cell lung cancer (NSCLC) stratified by epidermal growth factor receptor (EGFR) mutation status.

Findings: Patients with resectable histologically documented stage IIIA-N2 NSCLC were assigned to a neoadjuvant erlotinib arm or a gemcitabine/carboplatin (GC) arm based on EGFR mutation status. The primary endpoint was response rate (RR). Secondary endpoints were progression-free survival (PFS) and overall survival (OS). Twenty-four patients with IIIA-N2 NSCLC were enrolled in the trial from January 2008 until May 2011. The overall response rate was 41.7% and the PFS and OS were 7.9 and 23.2 months, respectively, in overall population. The RR was 58.3% (7/12) for the erlotinib arm with mutant EGFR and 25.0% (3/12) for the GC arm with wild type EGFR (P = 0.18). Median PFS was 6.9 months versus 9.0 months, respectively (P = 0.071). Median OS was 14.5 months for the erlotinib arm and 28.1 months for the GC arm (P = 0.201). No unexpected toxicities were observed.

Conclusions: The primary endpoint was met and biomarker-guided neoadjuvant treatment strategy in patients with IIIA-N2 NSCLC is feasible. Erlotinib alone in neoadjuvant setting of EGFR mutant population showed an improved response but without survival benefits.

Trial Registration: ClinicalTrials.gov NCT00600587 https://www.clinicaltrials.gov/ct2/show/NCT00600587?term=NCT00600587&rank=1.

Citing Articles

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Liu B, Liu X, Xing H, Ma H, Lv Z, Zheng Y Front Oncol. 2024; 14:1349172.

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